Small Plant News: Volume 6, Number 8

Demystifying Direct Observation
By Beth A. McKew, DVM
Direct observation. Those two words have been known to generate lots of different thoughts among small and very small plant owners. Having spent some time in the field myself, I’ve heard many dollars worth of “my two cents” about direct observation:

What is the point of watching someone else do the work?

Direct observation is a waste of time.

Why can’t I just directly observe myself?” (Sometimes followed by the question, “How am I supposed to directly observe myself?”)

Although the meaning and purpose of direct observation can be puzzling at times, with some clarification, direct observation actually makes sense.

Verification activities help support whether an establishment’s Hazard Analysis and Critical Control Point (HACCP) system is working effectively day to day. Direct observation is one of three ongoing verification activities specifically required by the regulations [Title 9 of the Code of Federal Regulations (CFR) 417.4 (a) (2) (i-iii)].

(i) The calibration of process-monitoring instruments;
(ii) Direct observations of monitoring activities and corrective actions; and
(iii) The review of records generated and maintained in accordance with § 417.5(a) (3) of this part.

Your plant’s HACCP system may include several other verification activities, but direct observation must be one of them. What does “direct observations of monitoring activities” mean?

Direct observation is primarily a way of verifying that monitoring activities are accomplished as prescribed by your HACCP plan. Think of monitoring as verifying the critical limits for specific production (lots), while verification provides a record of the ongoing execution of the written HACCP plan in a more general sense. Thus, while one employee monitors the critical control point, a second employee verifies that the first employee is performing the monitoring activity as described in the HACCP plan.

For example, if a critical control point is to measure and record finished product temperature in the cooler, then the ongoing verification activity of direct observation is performed by a second employee observing or watching the first employee actually take and record the temperature. The direct observer should be familiar with the critical control point in order to ensure that the activity is being performed as described in the HACCP plan, accounting for technique, equipment, location, time, or frequency as appropriate. By performing direct observation, you’re conducting ongoing verification that the monitoring procedure is being performed as intended.

Since direct observation is a required verification activity, it has a set of regulatory requirements that go with it. Your HACCP plan must describe what you’ll be observing and at what frequency the observation will occur. To allow for a wide variety of establishment sizes and production volumes, there is no one, prescriptive frequency described in the regulations; however, a frequency must be specified in your HACCP plan and the reason as to how you decided on that frequency must be documented. Frequencies for conducting verification activities will vary, depending on factors such as the type of process, volume of products, and the results of prior verification activities. Direct observation recordkeeping must include:

the results of the procedure performed,

the initials or signature of who performed the direct observation, and

the date and time it was performed

Remember: HACCP records are required to be recorded at the time the specific event occurs.

One exception to the direct observation regulation is for establishments with only one employee. One employee cannot watch him or herself; in this case FSIS would not require the direct observation verification activity. However, an establishment with two employees is expected to perform direct observation, even if the second employee does not routinely perform duties related to the activity being monitored. For example, if one employee works on the kill floor while the second employee only works in the office, the establishment is still required to perform the direct observation verification activity because they have more than one employee.

Another exception to the direct observation requirement is when your plant uses a continuous monitoring device or data logger. You don’t need to perform direct observation on the data logger at that critical control point. However, you do need to ensure that your employees perform procedures associated with monitoring the critical control point as per your HACCP plan. For example, you’ll need to set up the monitoring equipment as described in your HACCP plan and ensure that the continuous monitoring device is working.

Both a single-employee establishment and those establishments that utilize data loggers or continuous monitoring devices must perform other verification activities as described in their HACCP plan, including the required records review verification activity and the calibration of process-monitoring instruments.

One common misconception is that direct observation is a second monitoring event. The reason direct observation is in place is so you can verify that monitoring is being performed as described in your HACCP plan. Direct observation is not a second person monitoring the same critical control point at the same or a different time, just as it certainly is not the same person monitoring the same critical control point for a second time. Simply put, direct observation is not duplicate monitoring.

If you have further questions about direct observation, contact your FSIS inspection team, or submit your question to askFSIS at http://askFSIS.custhelp.com. You may also contact the Small Plant Help Desk.

Commonly Asked Questions & AnswersQ.What are computer-generated export stamps, and what are the procedures for their use?

A. A computer-generated export stamp is an exact impression of the official export inspection mark as identified in 9 CFR 312.8 and 9 CFR 381.104 and is applied to a shipping container in such a manner that the stamp cannot be reused.

Computer-generated export stamps may be used to mark product for export provided they are:

equal in size and an exact impression of the FSIS rubber export stamp;

not printed until authorized by the inspector on the basis of an assigned export certificate number;

printed only in the quantity needed for the consignment, and any excess stamps are destroyed after application to the consignment;

applied in such manner that reuse is prevented (must adhere well);

under the control of a designated, responsible plant employee; and

available to the FSIS program employee for reinspection.

The computer-generated export stamp can be printed on the same label that contains the labeling information required by FSIS and the importing country, provided that the six requirements stated in the previous paragraph are met. In the case where such labeling bears special claims or statements, FSIS Labeling and Program Delivery Staff (LPDS) approval must be obtained before the label can be used. The establishment is responsible for ensuring that the export stamp is properly applied to the product. An un-affixed label containing the export stamp is an accountable item and must be controlled in a similar manner as an FSIS rubber export stamp.